There is nothing more important to a medtech company—nor more confusing and misunderstood—than its intellectual property. An effective patent counsel is essential to a company to help it clarify and protect its most valuable asset. Two medical device experts from the intellectual property law firm Knobbe Martens highlight what to look for in an IP attorney who understands and can negotiate the medtech patent jungle.

1. MEDTECHSTRATEGIST.COM
See page 11
DECEMBER 6, 2016
Vol.3, No.17
MARKET TRACK
Published by Innovation In Medtech,llc
START-UPS TO WATCH
LEVEL EX:
A Virtual Simulator Transforms
Medical Education and Helps
Device Companies
Mary Stuart, 46
ORTOWAY:
A Gentle, Hydraulic Device
Achieves Vertebral Distraction
for a Wide Range of Lumbar
Spine Procedures
Mary Stuart, 48
PERSPECTIVE
A Post-Election First Take
for Device Manufacturers
Wendy Diller, 4
DIGITAL HEALTH
THE “SMART HEALTHCARE”
REVOLUTION:
Can Digital Tools, Advanced
Biosensors, and Data Analytics
Transform Healthcare as We Know It?
Mary Thompson, 8
Opportunities and Challenges in the
Digital Health Arena: A Conversation with
John Gardner of Nokia Growth Partners, 18
Israeli Start-Ups Exemplify Global Digital
Health Effort, 22
SPINE
NASS 2016:
Robotics, Safer Imaging
Take Center Stage
Wendy Diller, 24
Putting ASCs on J&J’s Commercial Map, 30
OUTSIDE OPINION
TEN SKILLS
Medical Device Companies Need
from Their Patent Attorneys
Paul Conover & Curtis Huffmire, 42
MEDTECH INVESTING
PEPPERMINT VENTURES:
Making the Connection
Between Medtech and Digital
David Cassak, 32
Digital Health Annual
Global Financing History

2. THE MEDTECH STRATEGIST © 2016 Innovation In Medtech, LLC. All rights reserved.
42 OUTSIDE OPINION
There is nothing more important to a medtech company—nor more
confusing and misunderstood—than its intellectual property. An
effective patent counsel is essential to a company to help it clarify
and protect its most valuable asset. Two medical device experts from
the intellectual property law firm Knobbe Martens highlight what
to look for in an IP attorney who understands and can negotiate the
medtech patent jungle.
TEN SKILLS
Medical Device Companies Need
from Their Patent Attorneys
Let’s face it—for most people, pat-
ent applications are painful to read.
They seem repetitive and redundant,
and use grammar and phrases that
would make your high school English
teacher scream. In some cases, this
language implements very sophisti-
cated and effective legal strategies,
and in other cases, it is just poor writ-
ing. If you are like most medical de-
vice company executives, you have
wondered at some point in your ca-
reer how you can judge a good patent
from a bad one, or, for that matter, a
good patent attorney from a bad pat-
ent attorney.
In a general sense, the patent pro-
fession is no different from most oth-
ers today. Our world has become very
complex, requiring a high degree of
training and specialization. In many
situations, at home or at work, we
have to trust professionals to use their
skill and judgment to provide impor-
tant services that are hard to evalu-
ate. But there are usually clues along
the way that can give us insight into
their level of competence. In the prac-
tice of patent law for medical device
companies, there are many hallmarks
of skillful patent counsel. As patent
attorneys with extensive experience
working with medtech clients, we
have come to learn what are the most
important skills in handling intellec-
tual property (IP) issues in the device
industry, and will highlight here what
we consider to be the top 10.
1Intense focus on
marketable medical
product features
Patent attorneys love technology.
All registered patent attorneys must
have a technical degree in addition to
their law degree, in a field such as en-
gineering, physics, chemistry, or biol-
ogy. Patent attorneys need to discuss
with their clients and understand the
particular technical hurdles that in-
vestors face and have to overcome in
creating new products. However, in a
patent application, fixating on the ini-
tial technical problems can often lead
to too much emphasis on one particu-
lar engineering solution that can easi-
ly be designed-around by competitors
in different ways.
Skillful patent attorneys for medical
device companies focus less on nar-
row engineering solutions and more
on what is marketable about a medi-
cal product, continually asking their
clients questions like “Why will doc-
tors and patients prefer this device?”;
“What will make this therapy better
than others on the market?”; “Why
will medical investors or large medi-
cal companies be attracted to your
company?”; or “What features of this
medical product will you be market-
ing most intensely?” These questions
elicit information that can help the
patent attorney to focus the patent
application on what really matters:
protecting the market-distinguishing
features from being copied, which will
add substantial value to a medical de-
vice company.
2Coherent explanations
of medical patent law
For most people, on the surface,
patent law can seem very confusing
and counterintuitive. Patent law for
medical companies can be especially
difficult because it involves some
principles that are unusually compli-
cated, including the patentability of
computer-based diagnostic methods
and patent coverage on devices with
disposables.
by
PAUL CONOVER &
CURTIS HUFFMIRE

3. DECEMBER 6, 2016
43OUTSIDE OPINION
Skillful patent attorneys steeped in
the patent law understand its logic
and the policies behind it, but they
recognize that their clients only need
to know and understand the particu-
lar principles of patent law that are
needed to make important business
decisions along the way. These at-
torneys find ways, with straightfor-
ward explanations and analogies, to
clearly convey the necessary legal un-
derstanding to their clients, without
veering off into irrelevant legal nu-
ances and without using legal jargon
or terminology that is unhelpful and
distracting. When a patent attorney’s
explanations of the law or technology
are clear to a client, they will prob-
ably be clear to the patent office and
to other attorneys and to potential in-
vestors or acquirers as well.
3Solid understanding of
medical technology
and ability to communicate
it simply
In the broadest sense, the job of
medical device patent attorneys is to
learn about and thoroughly under-
stand the cutting-edge technology in
a particular field of healthcare, deter-
mine how their client has improved it,
and then explain that technology and
improvements in ways that are under-
standable and persuasive. These skills
play a very important role in drafting
patent applications, convincing exam-
iners to grant patents, negotiating and
drafting licensing deals, and perform-
ing or defending diligence in acquisi-
tions and investments involving intel-
lectual property.
Background knowledge in a field is
always helpful, but it is not necessary
for patent attorneys to have deep ex-
perience in a particular medical tech-
nology in order to be qualified to work
in it. In fact, specialized knowledge of-
ten comes from representing another
company on the same type of prod-
ucts, which may create a conflict of
interest that can sometimes block the
most technically experienced patent
attorneys from taking on new work in
that specific area.
It is more critical for a patent attor-
ney to have a broad general under-
standing of medical technology and
the ability to quickly and efficiently as-
similate and understand the technical
underpinnings, the market trends, and
the improvements, and then, most im-
portantly—the ability to explain all of
these in understandable and relatable
ways, without becoming bogged down
in technical minutia.
4Frequent personal
interactions with
medical device patent
examiners
As with most things in business and
in life, personal interactions are near-
ly always more productive and more
persuasive than written communica-
tions. This is especially true in pros-
ecuting patent applications. Patent
examiners deal with a large amount of
dry technical information in special-
ized fields. Over time, the stream of
different patent applications probably
can run together in their minds. Per-
sonal interactions can help to make
a particular patent application stand
out. But surprisingly, many patent at-
torneys do not routinely conduct tele-
phone or in-person interviews with
patent examiners.
Personal interviews with patent ex-
aminers can be especially helpful in
medical device patent applications,
since an effective explanation of the
benefits of a medical invention can be
very compelling, involving the qual-
ity and longevity of life itself. Also, for
medical inventions, demonstrations of
prototypes interacting with diagrams
or models of anatomy can very effec-
tively dispel any misunderstandings
of the technology or refute an exam-
iner’s erroneous positions.
Perhaps most importantly, a person-
al interview creates personal account-
ability on the part of a patent exam-
iner to be reasonable. Skillful medical
device patent attorneys conduct per-
sonal interviews with patent examin-
ers as often as possible and develop
strategies for presenting the technol-
ogy and legal arguments in a convinc-
ing manner during the interviews. This
practice helps to build rapport and
credibility over time with the groups
of medical device examiners who they
work with on a continuing basis.
5Familiarity with
business stages of
medical companies
Medical device companies come in
all shapes and sizes. However, there
are some consistent aspects and stag-
es common to medical device com-
panies that make the industry unique
compared with other industries. Some
medical device companies quickly
advance from the start-up phase to
the funding phase to the acquisition
phase or, in rare cases these days, an
IPO. Others may have already devel-
oped into substantial companies with
specialized divisions. Along the way,
medical device companies are com-
monly dealing with a myriad of issues
including regulatory, reimbursement,
safety, product liability, research and
development, clinical trials, barriers to
entry, US versus foreign development
options, supply and distribution chan-
nels, and many other challenges facing
the medtech industry.
Patent strategy needs to take into
account the overall business objec-
tives, the stage of company develop-
ment, and the available IP budget in
view of these other pressing matters.
For example, at the start-up stage, the
importance of adequately protecting
key developments and establishing

4. THE MEDTECH STRATEGIST © 2016 Innovation In Medtech, LLC. All rights reserved.
44 OUTSIDE OPINION
clear ownership of the intellectual
property is critical. As the company
grows and begins to have significant
product offerings and to attract in-
vestors, there may be additional fo-
cus on assessing the potential risk
of infringing third party patents and
minimizing those risks. As the com-
pany moves toward acquisition or
IPO, a strong patent portfolio and
positions with respect to main com-
petitors can be important during the
diligence phase. An established com-
pany may have more ability to rein-
vest through research and develop-
ment, patenting new developments,
seeking licensing opportunities, and
policing its IP. Skilled patent attor-
neys will tailor patent strategy and
priorities to the business needs be-
ing addressed by the medical device
company. Attorneys with experience
advising medical device companies
have greater insight and ability to
navigate common issues. Skilled pat-
ent attorneys should be key advisors
and counselors for the company at all
stages.
6Diverse technical
expertise in firm for
medical companies
Products, systems and procedures
developed by medical device compa-
nies can extend into multiple techni-
cal areas. There may be new mechani-
cal components or patient interfaces,
computer software or hardware im-
provements, and pharmaceutical or
other chemical compositions involved
in treating a patient or manufacturing
a product. It is rare to find a patent
attorney that has expertise across all
technical fields that may be applicable
to the company.
Sometimes patent attorneys who
focus exclusively on a particular tech-
nical area can get into the mindset of
seeing the invention from their own
technical perspective. That focus may
carry over into drafting patent appli-
cations that are comfortably within
their technical skill set without fully
developing all aspects of the invention
that may be important to the compa-
ny. This may occur more frequently in
firms where the patent practice group
is smaller, or shares a common techni-
cal focus, even if the overall firm itself
may be large.
In contrast, firms that have larger
numbers of patent attorneys and di-
verse technical expertise can provide
unique advantages to their clients.
Skilled patent attorneys recognize
when important developments are
made by the company that may ex-
tend beyond their specific area of ex-
pertise. Those attorneys are comfort-
able reaching out to and cooperating
with others in their firm to provide
the company with the best patent so-
lutions across all technology areas. A
hallmark of skilled patent attorneys
is their ability to tap into the techni-
cal resources within their firm when
developments may extend beyond
their core practice area. As skilled pat-
ent attorneys take this approach, the
company, over time, can expect to
develop relationships with different
attorneys within the firm that may be
uniquely qualified to assist with de-
veloping particular strategies for the
company.
7Some experience
or training in the
courtroom
In general, most patent attorneys
focus their practices on either: (a)
obtaining patents, licensing pat-
ents, and evaluating patents for
transactions or freedom-to-oper-
ate or design-around efforts; or (b)
litigating patents in infringement
lawsuits. Even though this general
division exists, it can be extreme-
ly valuable for patent attorneys
whose practices involve obtaining,
licensing and evaluating patents to
have some experience in litigation
at some phase in their careers.
The process of litigating patents
in court exposes common vulner-
abilities in patents and highlights
patent language that can create
limitations or ambiguities. When
patent attorneys understand the
process of patent litigation first-
hand, they become very sensitized
to these issues and become much
more effective in drafting and
prosecuting effective patents, and
in performing transactions involv-
ing patents.
For medical device patent at-
torneys, litigation experience can
be especially helpful. In lawsuits
involving medical device patents,
the patent owner’s counsel must
often strike a careful balance be-
tween emphasizing the life-saving
or life-improving benefits of the
inventions, and justifying the po-
tential market-access limitations
created by patents and the likely
increased cost of the patented
technology as compared to a
competitor’s products. Patent at-
torneys who are involved in these
cases learn how judges and juries
respond to arguments regarding
medical device patents, and how to
create a better foundation to sup-
port these arguments in the pat-
ents that they draft.
As the company
moves toward
acquisition or IPO,
a strong patent
portfolio and
positions with
respect to main
competitors can be
important during the
diligence phase.

5. DECEMBER 6, 2016
45OUTSIDE OPINION
8Provides you with
updates in patent law
regarding medical devices
The patent law in the US and for-
eign countries is in constant flux. The
US Congress has implemented many
wide-ranging changes to the patent
statutes within the last few years,
and the US Patent Office continually
introduces new programs aimed at
improving patent examination and
speed that provide new options for
expediting patent applications and
interacting with patent examiners.
In addition, the US patent-appeals
court and Supreme Court issue nu-
merous decisions each year that
create binding legal precedents. It is
therefore crucial for patent attorneys
to continually study these changes in
the law and to adjust their practices
and strategies to achieve the maxi-
mum benefits for their clients.
But how does a medical device
company know whether its patent
counsel is keeping up with the new
developments in the law? In some sit-
uations, it may be a good idea to ask
your patent counsel about his or her
approach to keeping up on the law,
especially if any past experiences may
suggest problems. However, in most
cases, it is abundantly clear when pat-
ent attorneys are diligent in learning
about legal changes and implement-
ing new strategies because they con-
tinually provide updates on changes
in the law to their clients in strategy
discussions and discuss new ways of
responding to those changes.
9Stable team of
qualified attorneys
Medical device companies are de-
veloping cutting edge systems and
products. Skilled patent attorneys
need to develop a strong understand-
ing of the prior art technologies and
the unique aspects of the company’s
offerings and strategies. It takes time
and effort to develop that level of
familiarity with the company, the
improvements, the prior art, and
the business landscape. Over time,
both senior and junior patent attor-
neys will develop specialized tech-
nical knowledge, experience with
patent examiners, and a deeper un-
derstanding of industry players that
will be important to representation
of the company. This institutional
knowledge is a very valuable asset
to the company, and increases effi-
ciency and effectiveness in the rep-
resentation.
Unfortunately, attorneys who be-
come very familiar with the com-
pany’s strategy and portfolio some-
times leave their firm for various
reasons. Life brings change, and
some changes cannot be avoided.
However, some firms have a dispro-
portionately high degree of turnover
in their attorney ranks. If turnover
is high over an extended period of
time, several new attorneys may
have to be brought up to speed,
which can reduce the efficiency and
effectiveness of the representation,
and some institutional knowledge
can be lost.
Skilled patent attorneys seek to de-
velop a stable team of qualified at-
torneys to serve their clients. Using a
team framework fosters the sharing
of critical information among team
members and allows for new attor-
neys to be brought up to speed more
quickly and efficiently. An experi-
enced team will be able to handle
turnover without losing critical insti-
tutional knowledge and will be flex-
ible to the needs of the company as
they change over time. Skilled patent
attorneys should be managing teams
that have earned the company’s trust
and be able to make adjustments in
staffing matters that do not adverse-
ly impact the company’s strategy.
10Law firm highly
regarded in medical
device community
The reputation of a patent law firm
in the medical device community
can be very important, especially
for medical device companies in the
start-up, investment or acquisition
phases. When a well-regarded pat-
ent law firm with long experience
in the medical device field has been
engaged to prosecute a company’s
patents or to navigate around other
patents in the field or to explain the
company’s positions regarding intel-
lectual property in due diligence, the
level of credibility for the company
increases and the natural skepticism
on the part of those reviewing the
company’s technology and assets
decreases.
As noted, the intellectual property
of a medical device company is usu-
ally its most valuable asset, and it
should be entrusted only to patent
attorneys whose practices reveal a
high level of skill and competence.
When a medical device company’s
intellectual property is solid and se-
cure, the prospects for investment
and market success for life-improv-
ing and life-saving technologies are
maximized. However, figuring out
how to select an effective guide for
this journey can be difficult, frustrat-
ing and expensive. Hopefully the
suggested skills outlined above will
help ease this process.
Paul Conover Curtis Huffmire
Paul Conover (Paul.Conover@knobbe.
com) and Curtis Huffmire (Curtis.
Huffmire@knobbe.com) are partners
at Knobbe Martens, an intellectual
property law firm with a large medical
device practice.